FDA 510(k) Applications Submitted by RISHI SINHA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K230064 |
01/09/2023 |
Mazor X System (Mazor X Stealth Edition) |
Mazor Robotics Ltd. |
| K080625 |
03/05/2008 |
SMITH & NEPHEW MIS HIP STEM WITH STIKTITE |
SMITH & NEPHEW, INC. |
| K080875 |
03/31/2008 |
PIGALILEO 4TH GENERATION SYSTEM |
SMITH & NEPHEW, INC. |
| K151000 |
04/15/2015 |
O-Arm O2 Imaging System |
MEDTRONIC INC. |
| K071071 |
04/16/2007 |
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS |
SMITH & NEPHEW, INC. |
| K081124 |
04/21/2008 |
MDF REVISION HIP SYSTEM |
SMITH & NEPHEW, INC. |
| K121264 |
04/26/2012 |
TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE |
MEDTRONIC SURGICAL TECHNOLOGIES |
| K111520 |
06/02/2011 |
IPC POWEREASE SYSTEM |
MEDTRONIC XOMED, INC. |
| K141704 |
06/24/2014 |
NOVASHIELD INJECTABLE NASAL PACKING AND STENT |
MEDTRONIC INC. |
| K181859 |
07/12/2018 |
Visualase Thermal Therapy System |
Medtronic Navigation Inc. |
| K082267 |
08/11/2008 |
PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1 |
SMITH & NEPHEW, INC. |
| K072417 |
08/28/2007 |
SMITH & NEPHEW MIS HIP STEM |
SMITH & NEPHEW, INC. |
| K072858 |
10/05/2007 |
TC-PLUS PRIMARY KNEE SYSTEM |
SMITH & NEPHEW, INC. |
| K153247 |
11/09/2015 |
Fusion Compact Navigation System |
MEDTRONIC NAVIGATION, INC. |
| K073325 |
11/27/2007 |
LEGION POROUS PRIMARY |
SMITH & NEPHEW, INC. |
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